SCRO Standard Operating Procedures

1.0 Signature Authority

1.1 The Vice Chancellor for Research (VCR) is the UCB official authorized to approve stem cell research projects on campus. The VCR may delegate this authority to another campus official.

2.0 SCRO Committee Membership

2.1The Chair and members of the SCRO Committee (hereafter, SCRO) are appointed by and report to the Vice Chancellor for Research.

2.2 The term of usual term of service for committee members is two years.

2.3The SCRO will comprise up to 20 members, of which fivewill constitute a quorum with the proviso that the five include one member of the public, one patient advocate, one member with expertise in human stem cell (HSC) research, and one member with expertise in ethical aspects of HSC research.

2.4. No member may participate in the SCRO initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the SCRO. Members with a conflict of interest must be recused from the discussion and the vote of the protocol except to answer questions of the Committee about the proposed research.

2.5 The SCRO will be staffed by the SCRO Administrator.

3.0 SCRO Committee HSC Research Protocol Reviews

3.1 Levels of Review

  1.  
    1. Full Committee Review: Review conducted by at least a quorum of the SCRO. Full Committee Review may be held by tele/video conference at the discretion of the Chair.
    2. Subcommittee Review: Review by a subcommittee of at least three SCRO members including: 1) a member with expertise in the relevant science; 2) a member with expertise in the ethical aspects of HSC research; 3) a member with other relevant expertise. The subcommittees are appointed by the SCRO chair.
    3. Administrative Review: Review performed by SCRO staff with approval by the SCRO chair.

3.2 Types of Reviews

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    1. Full Committee Review is required for protocols that involve human stem cell research of the types described in Section IV E1 (a-e)of the UCB Human Stem Cell Research Policy.
      1. Research involving procurement of human oocytes
      2. Research involving use of fertilized human oocytes or blastocysts
      3. Research with the aim to derive or create a human pluripotent stem cell line
      4. Research introducing human pluripotent stem cell lines into non-human animals or introducing human neural progenitor cells into the brain of non-human animals at any state of embryonic, fetal, or postnatal development
      5. Research introducing human pluripotent stem cell lines into a live born human
    2. Administrative Review may be utilized in two circumstances:
      1. For research that is purely in vitro, utilizing previously derived human pluripotent stem cell lines which have been obtained from registries or cell banks enumerated in the UCB Human Stem Cell Research Policy Section IV F1 (a-d).
        1. Been listed on the National Institutes of Health Human Embryonic Stem Cell Registry; or
        2. Been deposited in the United Kingdom Stem Cell Bank; or
        3. Been derived by, or approved for use by, a licensee of the United Kingdom Human Fertilization and Embryology Authority; or
        4. Been derived in accordance with the Canadian Institutes of Health Research Guidelines for Human Stem Cell Research under an application approved by the National Stem Cell Oversight Committee.
      2. Forresearch utilizing human adult stem cells as defined in Section IV E1 (g) of the UCB Human Stem Cell Research Policy.
    3. Subcommittee Review may be utilized for research that is purely in vitro utilizing previously derived pluripotent stem cell lines obtained outside the sources listed in the UCB Stem Cell Research Policy, Section IV F1 (a-d).

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4.0 SCRO Committee Meeting Procedures

4.1 The SCRO will maintain a Web-based collaborative workspace, “bSpace”, which will be used for communication among committee members and with staff.

4.2 In advance of Full and Subcommittee Review meetings, copies of all protocol applications will be mounted on the SCRO’s bSpace website. The SCRO Administrator will notify members when the applications are available for their review and comments. Any member may provide comments on the applications whether or not they are able to attend the meeting. Comments may be emailed to the Administrator or posted on bSpace.

4.3 Protocols qualifying for Administrative Review will be mounted on the SCRO bSpace site. They may be approved by the chair 48 hours after circulation to the SCRO members if, during that period, the chairman receives no opposition to this action from any committee member.

4.4. At the time of his/her protocol application submission, the researcher must also submit to SCRO staff an electronic copy of his/her full research grant proposal(s) describing the stem cell research to be approved by the SCRO.

4.5 SCRO Full Committee or Subcommittee Review meetings may be conducted via video or tele-conference at the discretion of the Chair.

4.6 One member of the Full or Subcommittee Review committee will act as lead reviewer, presenting an overview of the protocol to the rest of the committee.

4.7 SCRO review may take place simultaneously with CPHS, ACUC, COI and any other required committee reviews. Final SCRO approval will occur only when the approvals of other relevant committees have been obtained.

4.8 Annual review of Continuing protocols previously approved by Full or Subcommittee review may, at the discretion of the SCRO, be approved by Administrative Review, provided that the protocol and funding source(s) are unchanged.

4.9 The SCRO may enter into Memoranda of Understanding (MOUs) with its counterparts in other institutions, allowing a single review on protocol applications involving multi-institutional collaborations.

4.10 In order for an MTA involving a human embryonic stem cell line to be completed, the Industry Alliances Office staff must confirm with the SCRO that there is SCRO approval for derivation or use of that line.

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5.0 SCRO Committee Meeting Documentation

5.1 SCRO Full Committee review meetings will be recorded.

5.2 The SCRO will maintain minutes of the meetings and relevant correspondence with investigators, including approvals and disapprovals. The minutes shall be in sufficient detail to show:

  1.  
    1. attendance at the meetings;
    2. actions taken by the SCRO;
    3. the vote on these actions including the number of members voting for, against, and abstaining;
    4. the basis for requiring changes in or disapproving research; and
    5. a written summary of the discussion of controversial issues and their resolution.

5.3 The SCRO will maintain copies of:

  1.  
    1. reviewed SCRO protocol applications for new and continuing projects;
    2. any funded grant proposals supporting approved research;
    3. reports of adverse events;
    4. correspondence with investigators;
    5. IRB and other applicable compliance committee approvals; and
    6. a list of SCRO members.

5.4 The SCRO will maintain an auditable database of:

  1.  
    1. HSC research conducted by UCB investigators
    2. HSC and cell lines derived or obtained by UCB investigators.

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6.0 SCRO Review Appeals Process

6.1 If a researcher disagrees with the decision of the SCRO, s/he can request an opportunity to present her/his case before the entire membership of the SCRO. Appeals must be in writing and submitted directly to the SCRO prior to an investigator’s personal presentation to the SCRO. Decision in this instance will be made by a “super majority” consisting of two thirds of the entire membership. Members unable to attend such an appeals review in person, must participate via video.